21 CFR 866.5170 — Breast Milk, Rhodamine, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5170
Identification
A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DGI | Breast Milk, Rhodamine, Antigen, Antiserum, Control | 1 | 0 | |
| DGM | Breast Milk, Antigen, Antiserum, Control | 1 | 0 | |
| DGN | Breast Milk, Fitc, Antigen, Antiserum, Control | 1 | 0 |
